Tirofiban Plus Aspirin Shows No Added Benefit in BAD-Related Stroke: JAMA
China: Researchers have found in a new study that among patients with branch atheromatous disease (BAD)-related stroke, adding tirofiban to aspirin did not reduce the risk of early neurological deterioration or recurrent/new stroke compared with aspirin alone. The combination also did not increase the risk of moderate or severe bleeding, suggesting no clear clinical benefit despite an apparently acceptable bleeding safety profile.
The findings come from the STRATEGY randomized clinical trial, published in JAMA Neurology by Yicong Wang of the Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China, and colleagues. BAD-related stroke is associated with a substantial risk of early neurological worsening and subsequent disability, but evidence supporting intensified antiplatelet treatment in these patients has remained limited.
The multicenter, double-blind, randomized, placebo-controlled trial was conducted at 38 hospitals in China between November 2022 and November 2024. Researchers enrolled patients aged 18 to 80 years with acute ischemic stroke attributed to BAD, confirmed by magnetic resonance imaging within 48 hours of symptom onset. Participants were followed for 90 days.
A total of 970 patients were randomized, including 486 assigned to intravenous tirofiban plus aspirin and 484 to placebo plus aspirin. Tirofiban was administered at 0.4 μg/kg/min for 30 minutes, followed by 0.1 μg/kg/min for 24 hours. All participants received a 300-mg loading dose of aspirin on the day of randomization, followed by 100 mg daily through day 90.
The trial revealed the following findings:
- The primary efficacy outcome of early neurological deterioration within 7 days or new stroke within 90 days occurred in 79 patients (17.1%) receiving tirofiban plus aspirin versus 89 patients (19.6%) receiving aspirin alone; the difference was not statistically significant (HR, 0.88).
- Moderate or severe bleeding occurred in 1 patient (0.2%) in the tirofiban-plus-aspirin group and none in the aspirin-alone group, with no significant difference between groups.
- Subgroup analysis indicated a potential benefit of tirofiban in patients with parent artery stenosis ≥30%, although this finding requires confirmation in further studies.
The study was limited by combining early neurological deterioration and new stroke into one outcome despite their differing mechanisms, lack of routine repeat CT scans that may have missed asymptomatic intracranial hemorrhage, and possible inclusion of lacunar infarctions. As the trial involved Chinese patients aged 18–80 years, the findings may not generalize to other populations or patients with transient ischemic attack. The study may also have been underpowered to detect a more modest but clinically relevant treatment effect.
Overall, adding tirofiban to aspirin did not significantly reduce early neurological deterioration or new stroke in BAD-related stroke and did not increase moderate or severe bleeding. Further studies are needed to identify patients who may benefit and determine the optimal timing and duration of intensified antiplatelet therapy.
Reference:
Wang Y, Liao X, Feng S, et al. Tirofiban for Branch Atheromatous Disease–Related Stroke: The STRATEGY Randomized Clinical Trial. JAMA Neurol. Published online August 31, 2026. doi:10.1001/jamaneurol.2026.2855
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